Contract manufacturing of orthopedic implants and instruments made of titanium, stainless steel and PEEK in Germany and the USA
hg medical GmbH
Raisting (DE) · Huntington, WV (USA)New on Amplifa
About hg medical
hg medical GmbH is a contract manufacturer of orthopedic implants and instruments for bone surgery with a focus on extremities and spine. The company manufactures bone screws, plates, rotating inserts and instruments to customer order and processes exclusively approved raw materials such as titanium, stainless steel and PEEK. The value chain includes CNC Swiss-type turning and multi-spindle turning (Tornos DECO, DECO EVO, Traub TNL, Index MS-8 22), fully automated HERMLE machining centers, deep-hole drilling for cannulating screws, cleaning, passivation, anodization, laser marking as well as packaging in a Class 7 cleanroom. Quality assurance is performed via optical and tactile CMM measurements; both sites are ISO 13485 certified and meet the requirements of FDA 21 CFR Part 820. In 2023, hg labs was opened as the in-house development and optimization center. Headquarters and production are located in Raisting (Bavaria), while hg medical USA operates a second production plant in Huntington, West Virginia. Customers are OEM manufacturers of orthopedic, trauma and surgical implants worldwide.
- Site
- Raisting
- Processes
- Milling (fully automated machining centers), Swiss-type turning on Tornos DECO, DECO EVO and Traub TNL turning centers (with deep-hole drilling, Multi-spindle turning (Index MS-8 22), Deep-hole drilling / cannulation of screws and rotating inserts, Cleaning, Passivation, Anodization, Laser marking
- Materials
- Titanium, Stainless steel, PEEK
- Certificates
- EN ISO 13485:2016 + AC:2018 + A11:2021, ISO 13485:2016, FDA 21 CFR Part 820, ISO 13485:2016 (DEKRA, since 2016)
- Founded
- 2007
- Employees
- 150+ (2020, site
- Industries
- Orthopedic implants (extremities, spine), Bone surgery, Medical technology OEM, Trauma and surgical implants
- 01
Engineering and prototyping (hg labs)
- 02
CNC Swiss-type turning (Tornos, Traub)
- 03
Multi-spindle turning (Index)
- 04
CNC milling (Hermle, fully automated)
- 05
Cleaning and passivation
- 06
Anodization
- 07
Laser marking
- 08
CMM measurement
- 09
Class 7 cleanroom packaging
Materials and Processes
Titanium
Core material for orthopedic implants such as screws and plates; approved in an implant-suitable material condition.
Stainless steel
Processed for implants and instruments of bone surgery.
PEEK
Medical-grade high-performance plastic, machinable on the turning and milling centers of hg medical.
Sites
Raisting
DEHeadquarters and production
- Lot size
- Prototype to series
- Materials
- Titanium, stainless steel, PEEK
- Tornos DECO Swiss-type turning machines
- Tornos DECO EVO
- Traub TNL turning centers
- Index MS-8 22 multi-spindle turning centers
- Hermle machining centers (fully automated)
- Fully automated cleaning and passivation system
- CMM measuring machines (optical/tactile)
- Class 7 cleanroom
Huntington, WV
USProduction (hg medical USA, LLC, 810 Memorial Blvd)
- Materials
- Titanium, stainless steel, PEEK
- CNC turning and milling centers
- Automated milling shop
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Milling (fully automated machining centers)Machining | – | – | – | – | Titanium, Stainless steel, PEEK |
| Swiss-type turning on Tornos DECO, DECO EVO and Traub TNL turning centers (with deep-hole drillingMachining | – | – | – | – | Titanium, Stainless steel, PEEK |
| Multi-spindle turning (Index MS-8 22)Machining | – | – | – | – | Titanium, Stainless steel, PEEK |
| Deep-hole drilling / cannulation of screws and rotating insertsMachining | – | – | – | – | Titanium, Stainless steel |
| CleaningSurface | – | – | – | – | – |
| PassivationSurface | – | – | – | – | Titanium, Stainless steel |
| AnodizationSurface | – | – | – | – | Titanium |
| Laser markingSurface | – | – | – | – | – |
| PackagingAssembly | – | – | – | – | – |
| Optical and tactile CMM measurement (quality assurance)Testing | – | – | – | – | – |
| Manufacturing of orthopedic implants and instruments to customer order (contract manufacturing)Engineering | – | – | – | – | Titanium, Stainless steel, PEEK |
| Production of bone screws, plates and instruments for orthopedic applicationsMachining | – | – | – | – | Titanium, Stainless steel |
7 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Swiss-type turning machine / turning center | Tornos DECO | – | – | – | – |
| Swiss-type turning machine / turning center | Tornos DECO EVO | – | – | – | – |
| Turning center | Traub TNL | – | – | – | – |
| Multi-spindle turning center | Index MS-8 22 | – | – | – | – |
| Machining center (fully automated) | Hermle | – | – | – | – |
| CMM measuring machine (optical and tactile) | – | – | – | – | – |
| Fully automated cleaning and passivation system | – | – | – | – | Raisting |
Additional services
Quality
Both production sites operate fully independent quality management systems according to ISO 13485 and meet the requirements of FDA 21 CFR Part 820. Optical and tactile CMM measurements, continuous internal audits as well as regular customer and external audits ensure traceability across the entire manufacturing process.
| Evidence | Raisting | Huntington, WV |
|---|---|---|
| EN ISO 13485:2016 + AC:2018 + A11:2021 | ||
| ISO 13485:2016 (DEKRA, since 2016) | ||
| FDA 21 CFR Part 820 |
History
- 2007
Foundation of hg medical following acquisition of the DARCO implant division by Wright Medical
- 2009
Construction of an additional production facility in Raisting
- 2011
Capacity expansion; 45 employees
- 2013
New building for cleaning, passivation, packaging, anodization and laser marking
- 2015
Foundation of hg medical USA; more than 130 employees
- 2016
Commissioning of a fully automated cleaning and passivation system; ISO 13485 certification of the US subsidiary
- 2018
Migration to GEWATEC software; focus on digitalization and Industry 4.0
- 2020
Nord Holding acquires majority stake; more than 150 employees
- 2021
Capacity expansion; three-shift operation during the corona pandemic
- 2022
Investments of more than 8 million euros in capacity, automation, CMM systems and Class 7 cleanroom
- 2023
Opening of hg labs, the in-house development and optimization center